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Vert. Non-Vert. Hip. Avoid direct comparisons of efficacy as treatments are not tested in comparator trials. RIS 5 (VERT-NA). RIS 5 (VERT-MN). RIS 2.5/5 (Hip Study). Strontium ranelate (SOTI) 1. **. (TROPOS ) 2. ** Subgroup/ post hoc analysis.

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  1. Vert Non-Vert Hip Avoid direct comparisons of efficacy as treatments are not tested in comparator trials RIS 5 (VERT-NA) RIS 5 (VERT-MN) RIS 2.5/5 (Hip Study) Strontium ranelate (SOTI)1 ** (TROPOS)2 ** Subgroup/post hoc analysis Zoledronic Acid3 Zoledronic Acid4 ** ALN 5/10 (FIT1) ALN 5/10 (FIT2) Denosumab5 Adapted from: Martin and Seeman. ClinSci 2007; 112:77 Meunier et al. NEJM 2004; 50:459 Reginster et al. JCEM 2005; 90: 816 Black et al. NEJM 2007; 356:1809 Lyles et al. NEJM 2007; 357:1799 Cummings et al. NEJM 2009; 361:756 Neer et al. NEJM 2001; 344:1434 RLX 60 (MORE) RLX 120 (MORE) *IBAN 2.5 *IBAN inter Teriparatide 20µg6 *PTH 1-84 Calcitriol Calcitonin Calcium Vitamin D 0.2 0.6 1.0 0.2 0.6 1.0 0.2 0.6 1.0 *Not available in Australia

  2. Phase II Extension: 8 years Denosumab (abstract) Total Hip BMD Extension Study All on Denosumab 60 mg Q6M Denosumab Parent Study 8 % Change (LSM + 95% CI) 6.8% 16.5% 16 6 Denosumab 12 4 Month 96 2 8 % Change (LSM + 95% CI) 0 Lumbar Spine BMD 4 Denosumab Placebo –2 0 Denosumab –4 –4 –6 0 72 0 96 72 12 24 36 48 12 24 36 48 Denosumab Placebo N = 124 N = 23 N = 124 N = 23 N = 87 N = 12 Placebo N = 124 N = 22 N = 88 N = 12 Denosumab Placebo N = 124 N = 22 McClung MR et al. Abstract and Oral Presentation, ASBMR Annual Meeting. San Diego, USA 2011

  3. Change in Cortical Porosity % Porosity Change at 12 months % Porosity Change at 12 months Placebo ALN DMAb Placebo ALN DMAb 60 10 40 5 20 0 0 –5 –20 –10 –40 0.2 0.4 0.6 0.8 0 5 10 15 PTH change (3-month AUC) Deciles of PTH AUC (adjusted for baseline CTX) Scatter plot, regression lines and 95% confidence regions Errors bars represent 95% CIs

  4. Stopping Denosumab FREEDOM - Time to first osteoporotic fracture during the off-treatment period (abstract/poster, post hoc) • Alternative therapies given in: • 42% - Placebo • 27% - Denosumab N = number of subjects at risk. Error bars represent 95% confidence intervals. Adapted from: Brown JP et al. J Bone Miner Res 26(Suppl 1):FR0446 and poster at ASBMR 2011, San Diego.

  5. Vert Fx (%/yr) Placebo Denosumab Denosumab EXTENSION Study FREEDOM Study 3.5 4.0 3.1% Yrs 1 2 3 4/5* 3.5 3.1% 3.0 3.1% 2.7% 2.6% 3.0 2.3% 2.5 *Annualized rate 2.2% 2.5 2.0% 1.9% 2.0 2.0 1.4% Non-VertFx (%/yr) 1.5 1.1% 1.2% 1.5 0.9% 1.1% 0.7% 1.0 1.0 0.5 0.0 0.5 0.0 Papapoulos S et al, J Bone Miner Res 2012;27:694

  6. Zol and MenBoonen 1066

  7. Change (%) % Change FNeck BMD 8 6 Z6 +4.5% 1.4% p<.0007 4 Z3P3 +3.1% 2 Start of extension trial 0 0 1 2 3 4 5 6 Yrs 60 Serum PINP (ng/mL) 40 Z3P3 20 Z6 Start of extension trial 0 Yrs 0 1 2 3 4 5 6

  8. Morphometric Vertebral Fractures by Treatment 15 RR=0.48 95%CI (0.3,0.9) P=0.03 PBO 10.9% 10 6.2%(30/486) % Patients 52% reduction ZOL 3.3% 3.0%(14/469) 5 Z3P3 Z6 0 Core study (Year 0-3) Extension study (Year 3-6) • Clinical vertebral fractures (n=11): NS

  9. Odanacatib and shallow resorption pits Leung et al Bone 2011;49:623

  10. Odanacatib 5 years LS BMD 14.0 12.0 10.0 8.0 6.0 4.0 2.0 0.0 - 2.0 50/50/50 mg 50/placebo/placebo 0 12 24 36 48 60 mths

  11. OC8 QCT and Finite Element Analysis Spine and Hip 2

  12. Oral Recombinant Calcitonin

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